Calls for papers
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MannKind Corporation announced that the FDA has approved the company’s sBLA for use of Afrezza inhaled dry powder insulin for the treatment of Type 1 and Type 2 diabetes in children aged 6 and older. Afrezza was… Read more . . .
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Jiangxi Kvvit Pharmaceutical is paying an undisclosed amount up front, plus potential milestones and royalties, to Merz Therapeutics to acquire the rights to develop and commercialize Merz’s Inbrija levodopa dry powder inhaler in mainland China,… Read more . . .
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Australian biotech Rage Bio, which has been developing an inhaled splice-switching oligonucleotide (SSO) for the treatment of COPD, has announced that it has changed its name to Atisama Therapeutics. According to the announcement, the name… Read more . . .
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According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.… Read more . . .
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Quince Therapeutics announced that it has agreed to acquire Orphai Therapeutics (formerly AI Therapeutics, formerly LAM Therapeutics) and its LAM-001 inhaled dry powder rapamycin (sirolimus) for $115 million up front and up to an additional… Read more . . .
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More than a year after the FDA approved Satsuma’s Atzumi (STS 101) intranasal dry powder dihydroergotamine for the treatment of migraine in adults, Satsuma parent company SNBL says that it is still trying to find… Read more . . .
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Vertex has stopped a Phase 1/2 study of VX-522 inhaled RNA therapy for the treatment of cystic fibrosis and has ceased development of the product, the company said in its most recent report of financial… Read more . . .
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Enterprise Therapeutics announced that a Phase 2 trial of ETD001, an inhaled epithelial sodium channel blocker, met its primary endpoint, demonstrating a statistically significant and clinically relevant improvement in lung function versus placebo after 28… Read more . . .
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According to Chance Pharmaceuticals, China’s National Medical Products Administration has accepted the company’s NDA for CXG87 budesonide / formoterol DPI for the treatment of asthma. The announcement emphasizes that the formulation is Chance’s own “improved… Read more . . .
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CDMO Hovione and Industrial Design Consultancy (IDC) have announced that their new single-use capsule-based nasal delivery device is now available exclusively as part of an integrated platform that includes Hovione’s intranasal drug development and manufacturing… Read more . . .
Upcoming Events
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September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal